Percutaneous endovascular apparatus for repair of aneurysms and arterial blockages

ABSTRACT

An endovascular apparatus is provided for treating the effects of vascular disease including aneurysms and arterial blockages using a percutaneous, minimally invasive technique. In one embodiment the endovascular apparatus includes a tubular sleeve having a cranial end, a first caudal branch, and a second caudal branch such that the tubular sleeve is shaped like an upside down “Y.” The apparatus further includes at least one expandable attachment device attached to the tubular sleeve for securing the endovascular apparatus to an interior wall of a vessel. The at least one expandable attachment device includes a plurality of telescoping segments similar to the telescoping segments of a presentation pointer. Accordingly, during percutaneous insertion of the endovascular apparatus into a patient the attachment device can be collapsed into a small profile. Once positioned at the site of the aneurysm the telescoping attachment device can be expanded to hold the endovascular apparatus in place adjacent the inner lumen wall.

RELATED APPLICATIONS

This application is a continuation of, and claims priority to, U.S.patent application Ser. No. 11/484,331, filed 10 Jul. 2006; which claimspriority to, and is a continuation-in-part of, U.S. patent applicationSer. No. 10/624,864, filed 22 Jul. 2003, now U.S. Pat. No. 7,101,393;which in turn claims priority to U.S. Provisional Patent Application No.60/397,745, filed 22 Jul. 2002. Each of the priority applications ishereby incorporated by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates generally to an endovascular apparatus forthe treatment of aneurysms or arterial blockages, and more particularly,to an endovascular apparatus having an expandable attachment device forsecuring the endovascular apparatus to an interior wall of a lumen.

BACKGROUND OF THE INVENTION

An abdominal aortic aneurysm is an abnormal enlargement or “ballooningout” of the arterial wall of the aorta in a region that passes throughthe abdominal cavity, usually below the renal arteries and above thecommon iliac arteries. The aneurysm may also extend into the commoniliac arteries. Such aneurysms are typically brought on by the weakeningof the arterial wall from vascular disease. Although abdominal aorticaneurysms often do not cause pain, unless treated, an aneurysm mayrupture causing a fatal hemorrhage in a patient.

In the past aortic aneurysms were treated almost exclusively by surgicalrepair. Specifically, the aneurysm would be resected and replaced by anartificial artery known as a prosthetic graft. Because of thesubstantial risks associated with such an invasive surgery, however,other treatments for aortic aneurysms have been proposed includingendovascular grafting.

Endovascular grafting involves the placement of a prosthetic graftwithin the lumen of the artery such that the graft spans the length ofthe aneurysm. In this manner the aneurysm can be excluded from thecirculatory system rather than resected. Using a catheter as adeployment device, the endovascular graft can be introduced into thevascular system percutaneously. Once the graft has been positioned atthe site of the aneurysm it can be attached to the vascular wall bothabove and below the aneurysm using expandable attachment devices toprevent movement of the graft after deployment.

To introduce an endovascular graft percutaneously, the graft must becollapsible into a small profile for negotiating the vascular system.Upon reaching the site of the aneurysm the graft and its attachmentdevices can be expanded into a desired shape using an inflating ballooncatheter or other actuator. A variety of expandable attachment deviceshave been proposed for securing an endovascular graft to an interiorwall of a vessel most of which use stents with hooks or barbs topenetrate the intima of the vessel. None of the proposed attachmentdevices, however, have been found to be ideally suited for use with anendovascular graft.

Accordingly an endovascular apparatus having a new expandable attachmentdevice is desired. The new attachment device ideally should be smallwith a low profile and should expand to many times its initial diameter.It also should exert enough radial force when expanded to fix into theaorta and thereby reduce blood leaks around the apparatus.

SUMMARY OF THE INVENTION

In a first aspect, an expandable attachment device for securing anendovascular apparatus to an interior wall of a lumen is provided. Theexpandable attachment device may include a plurality of telescoping armsthat are joined together to form an expandable ring. This ring mayfunction similarly to stents. The expandable attachment device may beattached to an endovascular apparatus for the treatment of aneurysms orblockages, such as a graft or stent, or to a heart valve and may includebarbs, hooks, or other fasteners about its perimeter for attaching tothe interior wall of a lumen. Because the attachment device can becollapsed to a size that can be fed through a vessel, the attachmentdevice and an associated endovascular apparatus can be deployedpercutaneously in a patient. Once positioned at the site of an aneurysmor arterial blockage, the telescoping attachment device can be expandedto hold the endovascular apparatus in place adjacent the inner lumenwall.

In a second aspect, an endovascular apparatus is provided for treatinganeurysms or arterial blockages using a minimally invasive technique.The apparatus includes a tubular sleeve having a cranial end and atleast one caudal branch. If the tubular sleeve includes a first caudalbranch and a second caudal branch then the tubular sleeve is shaped likean upside down “Y.” Accordingly, for the treatment of abdominal aorticaneurysms the cranial end may be positioned in the infrarenal aorta, thefirst caudal branch may be positioned in one of the common iliacarteries, and the second caudal branch may be positioned in the othercommon iliac artery. The tubular sleeve may be made from materialsconventionally used to make endovascular grafts including syntheticfabrics or films, DACRON™, (polyethylene terephthalate) or expandedpolytetrafluoroethylene (ePTFE) so as to define a lumen and so as to becollapsible during percutaneous insertion into a patient's vascularsystem.

The endovascular apparatus further includes an expandable attachmentdevice attached to the cranial end of the tubular sleeve for securingthe apparatus to an interior wall of a vessel above an aneurysm. Theexpandable attachment device comprises a plurality of telescoping armsthat are attached to form an expandable ring. Each telescoping arm issimilar to an expandable presentation pointer. Alternatively, eachtelescoping arm may function like an accordion. Accordingly, duringpercutaneous insertion of the endovascular apparatus into a patient, theattachment device can be collapsed into a small profile. Once theapparatus is positioned at the site of the aneurysm or blockage, theexpandable attachment device can be expanded to hold the endovascularapparatus in place adjacent the inner lumen wall. Fixation componentsmay be positioned around the perimeter of the attachment device and maybe partially embedded in the inner wall of the vessel to secure theattachment device.

The plurality of telescoping arms may be made from materials suitablefor use in the human body including stainless steel, plastic, or analloy of nickel and titanium generally known as NITINOL™. NITINOL iscommonly used in the manufacture of medical devices that are to bedeployed in a compressed state through a catheter because of its uniquethermal memory properties. For example, a NITINOL part may bemanufactured in a first condition and then cooled and compressed into asecond condition. When heated to the body temperature of the patient theNITINOL part will expand to its original first condition.

In another aspect one or more expandable attachment devices may beattached to the one or more caudal branches of the tubular sleeve forsecuring the one or more caudal branches to the interior of the vesselwall.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of an endovascular apparatusaccording to a first aspect;

FIGS. 2A-D show the endovascular apparatus of FIG. 1 in various statesor expansion;

FIG. 3 is a schematic illustration of an endovascular apparatusaccording to a second aspect;

FIG. 4A is a top view of an expandable attachment device according to afirst aspect in a fully collapsed state;

FIG. 4B is a top view of the expandable attachment device of FIG. 4A ina partially expanded state;

FIG. 4C is a top view of the expandable attachment device of FIG. 4A ina fully expanded stated;

FIG. 5 is a locking mechanism according to a first aspect in a firstposition;

FIG. 6 is the locking mechanism of FIG. 5 in a second position;

FIG. 7 is a cross section of a segment of a telescoping arm according toa first aspect;

FIG. 8 is an endovascular apparatus according to a third aspect;

FIG. 9 is an endovascular apparatus according to a fourth aspect;

FIG. 10 is an illustration of a typical abdominal aortic aneurysmlocated in the infrarenal aorta;

FIG. 11 is a catheter for percutaneous introduction of an endovascularapparatus into a body lumen;

FIG. 12A is a schematic top view of an expandable attachment deviceaccording to a second aspect in a partially expanded state;

FIG. 12B is a schematic top view of the expandable attachment device ofFIG. 12A in a fully expanded stated;

FIG. 12C is a schematic side view of the expandable attachment device ofFIG. 12A;

FIG. 12D is a schematic side view of the expandable attachment device ofFIG. 12B;

FIGS. 13A-G are schematic top views of an expandable attachment deviceaccording to a third aspect in various states of expansion;

FIGS. 13H-N are schematic side views of the expandable attachment deviceof FIGS. 13A-G;

FIGS. 13O-T are schematic isometric views of the expandable attachmentdevice of FIGS. 13A-G;

FIG. 13U is a schematic illustration of another embodiment of theinvention.

FIG. 14 is a schematic illustration of the endovascular apparatus ofFIG. 1 having telescoping support columns;

FIG. 15 is a schematic illustration of an endovascular apparatusaccording to another aspect;

FIG. 16 is a schematic illustration of an expandable attachment deviceaccording to another aspect; and

FIG. 17 is a schematic illustration of a telescoping catheter forpercutaneous introduction of an endovascular apparatus into a bodylumen.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

An endovascular apparatus 10 according to a first aspect is shown inFIG. 1. The endovascular apparatus 10 includes a tubular sleeve 12having a cranial end 14, a first caudal branch 16, and a second caudalbranch 18. In other embodiments, termed “uni-iliac” devices, the tubularsleeve 12 may include only a single caudal branch. The tubular sleevemay be made from DACRON, ePTFE, peritoneum, fascia, or other commongraft material so as to form a flow path for by-passing an aneurysm.

The endovascular apparatus 10 further includes a first expandableattachment device 20 attached to the cranial end 14 of the tubularsleeve 12, a second expandable attachment device 22 attached to thefirst caudal branch 16 of the tubular sleeve 12, and a third expandableattachment device 24 attached to the second caudal branch 18 of thetubular sleeve 12. The expandable attachment devices 20, 22, 24 mayinclude holes 26 which may be sewn or sutured to the tubular sleeve 12.Alternatively, in lieu of holes 26, the expandable attachment devicescan be woven into the sleeve.

In another embodiment, the endovascular apparatus 10 may include afourth expandable attachment device 28 that is attached to the firstexpandable attachment device 20 by support columns 30. The fourthexpandable attachment device 28 may be positioned above a patient'srenal arteries, superior mesenteric artery or celiac artery. The supportcolumns 30, which may be made from NITINOL or stainless steel, mayprovide columnar support and strength for the endovascular apparatus 10while permitting blood flow to arteries located between the firstexpandable attachment device 20 and the fourth expandable attachmentdevice 28.

The support columns 30 may be either wires or tubes. If tubular, thesupport columns 30 may also be telescoping. For example, in anotherembodiment depicted in FIG. 14, the support columns 31 may comprise aplurality of incrementally sized segments that are slideably engaged andfit within one another. Thus, in this embodiment the endovascularapparatus 10 may be inserted percutaneously into a vessel with thesupport columns 31 contracted such that the axial distance between thefirst expandable attachment device 20 and the fourth expandableattachment device 28 is reduced. During deployment of the endovascularapparatus 10 the support columns 31 may be expanded, thereby permittingthe first expandable attachment device 20 to be positioned below therenal arteries while the fourth expandable attachment device ispositioned above the renal arteries. In yet another embodiment, shown inFIG. 14, the tubular support columns 30, 31, whether telescoping or nottelescoping, may contain an adhesive and include ports or apertures 33such that the adhesive can escape the support columns 30, 31 upondeployment to assist in securing the endovascular apparatus 10 to thewall of a vessel.

As illustrated in FIGS. 2A-2D, the endovascular apparatus 10 iscollapsible for easy insertion and navigation through a patient'svascular system using a catheter. Particularly, as illustrated in FIG.2A, the attachment devices 20, 22, 24, and 28 may be radially collapsedinto a profile that is small enough to fit in a catheter sheath. Whenthe attachment devices 20, 22, 24, 28 are deployed from the sheath atbody temperature, the devices may be expanded by a balloon or otheractuator to a size and shape in which they are able to retain the sleeve12 against the wall of a vessel.

The endovascular apparatus 10 according to a second aspect is shown FIG.3 in which the tubular sleeve 12 is supported by support columns 32. Thesupport columns 32 may attach the first expandable attachment device 20to a fifth expandable attachment device 34. Likewise, the supportcolumns 32 may attach the second and third expandable attachment devices22, 24 to the fifth expandable attachment device 34 which may be locatedat the juncture of the first caudal branch 16 and the second caudalbranch 18 of the tubular sleeve 12. In addition the support columns 32may be sewn or sutured to the exterior of the tubular sleeve 12. Thismay provide continued columnar support throughout the endovascularapparatus 10 to prevent migration within the vessel. The support columns32 may be telescoping as described with respect to FIG. 14.

Referring to FIG. 4A, an expandable attachment device 20 according to afirst aspect is shown in a fully collapsed state. The attachment device20 includes a plurality of fixation components 36 positioned about theperimeter of the device 20. A port 38 is located at the center of theattachment device 20. The port 38 is sized so as to receive a balloon orother actuator during deployment. The balloon may be inflated to expandthe attachment device 20 after insertion into a vessel. FIG. 4B showsthe attachment device 20 in a partially expanded state. FIG. 4C showsthe attachment device 20 in a fully expanded state. While in a preferredembodiment, the fixation component can have angular corners, in otherembodiments, the fixation component can have curved, rounded, or ovoidedges. Similarly, the entire corner or edge of each fixation componentneed not be the same shape throughout the length of the edge or corner.

Referring to FIG. 4C, a telescoping arm 40 is used to attach eachfixation component 36 to an adjacent fixation component 36. Thetelescoping arm 40 may be pivotably attached to a fixation component 36at one or both ends of the arm 40. A telescoping arm 40 is made up of aplurality of segments 42. The segments 42 may be in slideable contactwith one another and may be incrementally sized so as to fit within oneanother. For example, each telescoping arm 40 may be constructed fromwhat is referred to generally as “nested tubes.” When the telescopingarms 40 are fully extended the attachment device 20 may resemble apolygon having fixation components 36 located at its vertices. Thefixation components 36 may include barbs or prongs 67 (shown in FIG. 8)for fixation to a vessel wall. In another embodiment shown in FIG. 16,the telescoping arms 40 may contain an adhesive and include ports orapertures 41 such that the adhesive can escape the telescoping arms upondeployment to assist in securing the endovascular apparatus 10 to thewall of a vessel.

As one of ordinary skill might appreciate, the attachment device maytake variety of shapes depending upon the configuration of thetelescoping arms 40 and the fixation components 36. For example,referring to FIGS. 12A-D, the telescoping arms 40 may be positioned in asingle plane. Alternatively, referring to FIGS. 13A-T, the telescopingarms 40 may be positioned in multiple planes in, for example, what isreferred to herein as an “M configuration.” One possible advantage ofthe M configuration is that it may produce superior radial force forholding the attachment device in position. In addition, the Mconfiguration may produce the same ratio of expansion (i.e., the ratioof the final outer diameter of the attachment device in its expandedstate to the initial outer diameter of the attachment device in itscollapsed state) as the “single plane configuration” using fewer parts.

FIG. 13U depicts multiple “M configuration” attachment devices on anendovascular apparatus.

To keep the telescoping arms 40 in their final extended state afterdeployment in a vessel, a one-way latch may be used to lock adjacentsegments 42. FIG. 5 shows one possible latch 44, in a first position,for locking the telescoping arms 40. The latch 44 may consist of a oneor more grooves 46 associated with a first segment 48 and a tooth 50associated with a second, adjacent segment 52. As the telescoping arm 40is expanded, the second segment 52 moves in a first direction A relativeto the first segment 48. The tooth 50 and the grooves 46 are aligned soas to engage when the telescoping arm 40 is extended. Once the tooth 50engages a groove 46, as shown in FIG. 6, the second segment 52 may notmove in a second direction B relative to the first segment 48.Accordingly, the telescoping arm 40 is free to extend but may notcollapse once extended. Of course other one-way latches may be used tolock the segments 42 of the telescoping arms 40. FIG. 7 illustrates onepossible cross-section of a segment 42 of the telescoping arm 40. This“rail” design permits room for sliding and positioning of a one-waylatch, like the one shown in FIG. 5, between segments 42 shown in FIG.4.

FIG. 8 shows the endovascular apparatus 10 according to a third aspect.In the embodiment shown in FIG. 8, the endovascular apparatus 10includes a double-expandable attachment device 60 in the place of thefirst expandable attachment device 20. The double-expandable attachmentdevice 60 comprises an upper expandable attachment device 62 and a lowerexpandable attachment device 64 which are separated by and attached toan o-ring seal 66. The upper attachment device 62 is angularly offsetfrom the lower attachment device 64 so that the fixation components 36of each are offset. The fixation components 36 may include prongs orbarbs 67 to aid in securing the expandable attachment devices 62, 64 tothe vessel wall. This design provides for secure attachment to thevessel wall with reduced leakage around the perimeter of the attachmentdevice 60. The lower expandable attachment device 64 may be attached tothe tubular sleeve 12. The upper expandable attachment device 62 may beattached to the fourth expandable attachment device 28 by supportcolumns 30.

Referring to FIG. 9, the endovascular apparatus 10 according to fourthaspect is shown. In this embodiment a plurality of “M springs” 68 areattached to the cranial end 14 of tubular sleeve 12 as graft expandersin order to hold the tubular sleeve 12 open. In this manner the Msprings 68 may reduce leakage around the perimeter of the tubular sleeve12. M springs 68 may also be used to hold the caudal ends 16, 18 of thetubular sleeve 12 open. In the embodiment shown in FIG. 9, the M springs68 are not attached to the segments 52 of the telescoping arms 40 andare located on the exterior of the tubular sleeve 12. In anotherembodiment, the M springs 68 may be located on the interior of thetubular sleeve 12 or attached to the fixation components 36. Of course,in place of the “M springs” 68, springs in the shape of a “V” may beused. Alternatively, in another embodiment depicted in FIG. 15, the Msprings 68 may be replaced by telescoping arms 40 in an “Mconfiguration.”

FIG. 10 illustrates a typical abdominal aortic aneurysm 70 located inthe infrarenal aorta 71. The infrarenal aorta 71 is that portion of theaorta 72 located below the renal arteries 74, 76. As shown in FIG. 10,abdominal aortic aneurysms typically occur below the renal arteries 74,76 and above the common iliac arteries 78, 80. In some cases, theaneurysm includes the common iliac arteries 78, 80. The endovascularapparatus 10 may be used to treat or repair an abdominal aortic aneurysm70, like the one shown in FIG. 10, by excluding the weakened aneurysmalaortic wall from pressurized and pulsatile flow. In addition, theendovascular apparatus 10 may be used to treat aneurysms or blockageslocated in other body lumens such as the thoracic aorta, iliac arteries,subclavian arteries, urinary tract, bile tract, intestinal tract, etc.

The endovascular apparatus 10 may be deployed at the site of an aneurysmpercutaneously using a catheter 82 like the one shown in FIG. 11. Thecatheter 82 may have an IV port 84, a sheath 86 and an introducer 88which can be withdrawn within the sheath 86. Using the catheter 82, thedevice can be introduced percutaneously through either of the femoralarteries. As shown in FIG. 17, using a “nested tube” design similar tothe one utilized by the telescoping arms 40 of the attachment device 20,the catheter 82 may also be made to be telescoping.

During deployment the first expandable attachment device 20 may bepositioned just below the renal arteries 74, 76 and seated with anexpandable balloon or other actuator. The fourth expandable attachmentdevice 28 may be positioned superior to the renal arteries 74, 76, themesenteric artery, or the celiac artery and seated with an expandableballoon. After the first attachment device 20 is seated, the secondexpandable attachment device 22 may be positioned in a first iliacartery 78 and seated with an expandable balloon or other actuator. Thethird expandable attachment device 24 may be positioned such that itrests at a second iliac artery 80. To position and seat the thirdattachment device 24, access may be obtained percutaneously through thesecond iliac artery 80.

What is claimed is:
 1. An endovascular apparatus comprising: a tubularsleeve having a central lumen extending longitudinally between a cranialend portion and a caudal end portion, the cranial end portion includinga cranial end opening and the caudal end portion including at least onecaudal end opening; and a double-expandable attachment device extendingcircumferentially around the cranial end opening of the tubular sleeve,the double-expandable attachment device including: an upper expandableattachment device including a plurality of fixation componentsconfigured to fix the apparatus to a vessel wall and positioned aboutthe perimeter of the upper expandable attachment device, and a pluralityof circumferentially extending arms, each arm being used to attach eachfixation component to a circumferentially adjacent fixation component, alower expandable attachment device including a plurality of fixationcomponents configured to fix the apparatus to a vessel wall andpositioned about the perimeter of the lower expandable attachmentdevice, and a plurality of circumferentially extending arms, each armbeing used to attach each fixation component to a circumferentiallyadjacent fixation component, the lower expandable attachment deviceconnecting the double-expandable attachment device to the cranial endopening of the tubular sleeve, and an o-ring seal located longitudinallybetween, and connecting the upper expandable attachment device and thelower expandable attachment device, the o-ring seal being configured toreduce leakage around the perimeter of the double-expandable attachmentdevice at the cranial end opening.
 2. The endovascular apparatus ofclaim 1, wherein the caudal end portion of the tubular sleeve includes afirst caudal branch laterally separated from a second caudal branch, thefirst and second caudal branches each including a branch openingoriented in a caudal direction.
 3. The endovascular apparatus of claim2, wherein at least one of the first and second caudal branches includesa branch expandable attachment device extending circumferentiallytherearound and attached thereto.
 4. The endovascular apparatus of claim3, wherein each branch expandable attachment device includes: aplurality of fixation components positioned about the perimeter of theexpandable attachment device; and a plurality of circumferentiallyextending arms, each arm being used to attach each fixation component toa circumferentially adjacent fixation component.
 5. The endovascularapparatus of claim 1, wherein the caudal end opening includes a caudalend expandable attachment device extending circumferentially around thecaudal end portion of the tubular sleeve.
 6. The endovascular apparatusof claim 5, wherein the caudal end expandable attachment deviceincludes: a plurality of fixation components positioned about theperimeter of the expandable attachment device; and a plurality ofcircumferentially extending arms, each arm being used to attach eachfixation component to a circumferentially adjacent fixation component.7. The endovascular apparatus of claim 1, wherein at least the arms ofthe double-expandable attachment device are selectively collapsible inthe circumferential direction to selectively and reversibly reduce atotal circumference of the double-expandable attachment device from anexpanded apparatus condition to a collapsed apparatus condition.
 8. Theendovascular apparatus of claim 4, wherein at least the arms of thebranch expandable attachment device are selectively collapsible in thecircumferential direction to selectively and reversibly reduce a totalcircumference of the branch expandable attachment device from anexpanded apparatus condition to a collapsed apparatus condition.
 9. Theendovascular apparatus of claim 6, wherein at least the arms of thecaudal end expandable attachment device are selectively collapsible inthe circumferential direction to selectively and reversibly reduce atotal circumference of the caudal end expandable attachment device froman expanded apparatus condition to a collapsed apparatus condition. 10.The endovascular apparatus of claim 1, wherein at least onecircumferentially extending arm of the double-expandable attachmentdevice is a telescoping arm having a plurality of segments in slideablecontact with one another.
 11. The endovascular apparatus of claim 4,wherein at least one circumferentially extending arm of the branchexpandable attachment device is a telescoping arm having a plurality ofsegments in slideable contact with one another.
 12. The endovascularapparatus of claim 6, wherein at least one circumferentially extendingarm of the caudal end expandable attachment device is a telescoping armhaving a plurality of segments in slideable contact with one another.